The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | June 2014 |
End Date: | December 2014 |
Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy Subjects
The purpose of this study is to test whether Rifampin affects blood levels of istradefylline
in humans. Rifampin could possibly decrease istradefylline levels.
in humans. Rifampin could possibly decrease istradefylline levels.
Inclusion Criteria:
- Healthy non-smoking male and post-menopausal female subjects
- Body Mass Index: 18.0-35.0 kg/m2, inclusive
- Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or
CYP1A2.
- Subjects without clinically significant medical history in the judgment of the
investigator
- Subjects without clinically significant laboratory or ECG abnormalities
Exclusion Criteria:
- Females that are pregnant or lactating
- Administration of an investigational drug within 30 days or 5 elimination half-lives
of such investigational drug, whichever is longer, prior to study drug
administration, or planned administration of another investigational product or
procedure during the subject's participation in this study;
- Known history of treatment for drug or alcohol addiction within the previous 12
months;
- Subjects with an average alcohol intake of more than 2 units per day or 14 units per
week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is
½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
- Donated or lost > 500 mL of blood within 3 months prior to istradefylline dose on Day
1 of Period 1;
- Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface
antigen, or Hepatitis C;
- Positive test results for drugs of abuse at screening;
- Unable, or unwilling to tolerate multiple venipunctures;
- Difficulty fasting or eating the standard meals that will be provided;
- Use of tobacco or nicotine-containing products within 90 days of the study start to
the Follow-up visit
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